Evidence-based Medicine Center, Medical School of Nantong University , Jiangsu, China.
Department of Gastroenterology, Lianyungang No 1 People's Hospital , Jiangsu, China.
Expert Rev Anti Infect Ther. 2020 Aug;18(8):823-834. doi: 10.1080/14787210.2020.1760843. Epub 2020 May 12.
Chronic hepatitis B (CHB) is a major global health problem caused by hepatitis B virus (HBV) infection, and can put patients at high risk of death from cirrhosis and liver cancer. However, CHB can be treated with nucleos(t)ide analogues. We aimed to evaluate the effectiveness and safety of nucleos(t)ide analogues for the treatment of CHB patients.
A systematic literature search was performed. Direct comparison meta-analyses and network meta-analysis (NMA) were carried out.
Thirty-six randomized controlled trials (RCTs) met inclusion criteria. Compared with placebo, the nucleos(t)ide analogues were all effective in HBeAg seroconversion, HBeAg loss, and achieving undetectable HBV DNA. Telbivudine was associated with higher HBeAg seroconversion compared with entecavir. For HBeAg loss rate and proportion of achieving undetectable HBV DNA, tenofovir ranked as the best. Entecavir might be the most potent in the normalization of alanine aminotransferase (ALT). The nucleos(t)ide analogues did not have higher serious adverse events rate as compared with placebo.
The nucleos(t)ide analogues are all effective for HBeAg seroconversion, HBeAg loss, undetectable HBV DNA, and most are effective for ALT normalization in adults with CHB. RCTs of multi-center, low risk of bias, and long-term follow-up are still needed.
慢性乙型肝炎（CHB）是由乙型肝炎病毒（HBV）感染引起的全球性重大健康问题，可使患者面临肝硬化和肝癌死亡的高风险。然而，CHB 可以用核苷（酸）类似物治疗。我们旨在评估核苷（酸）类似物治疗 CHB 患者的疗效和安全性。
进行了系统的文献检索。进行了直接比较荟萃分析和网络荟萃分析（NMA）。
符合纳入标准的 36 项随机对照试验（RCT）。与安慰剂相比，核苷（酸）类似物在 HBeAg 血清学转换、HBeAg 丢失和实现 HBV DNA 不可检测方面均有效。替比夫定与恩替卡韦相比，HBeAg 血清学转换率更高。在 HBeAg 丢失率和实现 HBV DNA 不可检测的比例方面，替诺福韦排名最佳。恩替卡韦可能在丙氨酸氨基转移酶（ALT）正常化方面最有效。核苷（酸）类似物的严重不良事件发生率并不高于安慰剂。
核苷（酸）类似物在 HBeAg 血清学转换、HBeAg 丢失、HBV DNA 不可检测方面均有效，并且在大多数情况下对 CHB 成人的 ALT 正常化有效。仍需要多中心、低偏倚风险和长期随访的 RCT。
